Common use of License and Authorization Clause in Contracts

License and Authorization. 2.1 Subject to the terms, conditions and limitations hereof, including the conditions set forth in Section 3, Supernus hereby grants to Zydus a non-exclusive license, under the Licensed Patents to: (i) Manufacture, have Manufactured, import, use and Market the Zydus Product in, into or for the Territory, on and after the applicable Zydus License Date; and (ii) Manufacture, and have Manufactured, import and conduct regulatory activities regarding the Zydus Product in, into or for the Territory prior to the Zydus License Date (but not to Market or Ship the Zydus Product prior to the Zydus License Date) in sufficient quantities to permit Zydus to Market and Ship the Zydus Product in, into or for the Territory beginning ** prior to the Zydus License Date, (iii) beginning ** prior to a date in good faith anticipated by Zydus to be the date ** This portion has been redacted pursuant to a confidential treatment request. that a Final Court Decision will be entered finding all the claims of the Litigated Patents asserted and finally adjudicated against a Third Party with respect to a Generic Equivalent Product to be invalid, unenforceable or not infringed by such Generic Equivalent Product (a “Potential Final Court Decision”), Manufacture, and have Manufactured, import and conduct regulatory activities regarding the Zydus Product in, into or for the Territory prior to the Zydus License Date (but not to Market or Ship the Zydus Product prior to the Zydus License Date) in sufficient quantities to permit Zydus to Market and Ship the Zydus Product in, into or for the Territory on and after the Zydus License Date; provided that all Zydus Product remain at Zydus’ or its distributor’s warehouse until a Zydus License Date; and further provided, that Zydus shall re-export (or, at Zydus’ option, destroy) any Zydus Product which remains in the Territory at such time that Zydus in good faith determines that no such Final Court Decision will be issued with respect to a Third Party’s Generic Equivalent Product and no Accelerated License Date will result from such Potential Final Court Decision. To the extent Supernus owns or controls any regulatory exclusivities granted by the FDA that may prevent or hinder Regulatory Approval or Marketing of the Zydus Product, Supernus hereby waives, effective as of the date that Zydus is licensed to conduct the applicable activity hereunder, such exclusivities. Supernus shall, if requested by Zydus, send the FDA a written confirmation of Supernus’ grant of the foregoing license under the Licensed Patents and Supernus’ agreement to waive, effective as of the date that Zydus is licensed to conduct the applicable activity hereunder, such regulatory exclusivities with respect to the Zydus Product or the Zydus ANDA. 2.2 The license and authorization granted in Section 2.1 and Section 3.1 of this License Agreement are referred to herein as the “License and Authorization.” Except to the extent permitted pursuant to Section 11.3, and without derogating from Zydus’s “have Manufactured” rights set forth in Section 2.1, Zydus and its Affiliates shall not have the right to sublicense, assign or transfer any of its rights under the License and Authorization. 2.3 In the event the ** becomes effective due to an ** and there are thereafter no longer any ** the ** in the ** (other than ** or ** subject to substantially the same provisions as set forth in this Section), ** from **, ** to ** under the ** shall immediately terminate, and ** and its ** shall ** (no ** than the ** of the ** following Zydus’ receipt of such notice) the ** and ** of ** until such subsequent ** as another event constituting a ** shall have occurred. 2.4 Except as set forth in the License and Authorization or expressly set forth in this License Agreement or other Settlement Documents, there are no authorizations, licenses or rights granted by either Party under this License Agreement, by implication, estoppel or otherwise, including any right granted to Zydus or its Affiliates to Market or Manufacture any Generic Equivalent Product except under the Zydus ANDA. All rights not expressly granted by Supernus herein are hereby retained by Supernus. In addition, except as expressly set forth in this License Agreement or other Settlement Documents, Supernus explicitly retains the right itself or through an Affiliate to Market an AG Product, and Supernus is free to grant a license under the Licensed Patents or supply AG Product to any Third Party. 2.5 shall ** to ** (i.e., ** shall be **) as ** to the **. ** This portion has been redacted pursuant to a confidential treatment request.

Appears in 1 contract

Sources: Settlement Agreement (Supernus Pharmaceuticals Inc)

License and Authorization. 2.1 2.1. Subject to the terms, conditions conditions, and limitations hereof, including the conditions set forth in Section 3, Supernus hereby grants to Zydus a non-exclusive license, under the Licensed Patents to: (i) Manufacture, have Manufactured, import, use use, and Market the Zydus 200 mg Product in, into into, or for the Territory, on and after the applicable Zydus 200 mg Product License Date; and (ii) Manufacture, and have Manufactured, import import, and conduct regulatory activities regarding the Zydus 200 mg Product in, into into, or for the Territory prior to the Zydus 200 mg Product License Date (but not to Market or Ship the Zydus 200 mg Product prior to the Zydus 200 mg Product License Date) in sufficient quantities to permit Zydus to Market and Ship the Zydus 200 mg Product in, into into, or for the Territory beginning [** *] prior to the Zydus 200 mg Product License Date, (iii) beginning [** prior *] to a date in good faith anticipated by Zydus to be the date ** This portion has been redacted pursuant to a confidential treatment request. that a Final Court Decision will be entered finding all the claims of the Litigated Patents asserted and finally adjudicated against a Third Party [**] with respect to a Generic Equivalent 200 mg Product to be invalid, unenforceable unenforceable, or not infringed by such Generic Equivalent 200 mg Product (a “Potential Final Court Decision”), Manufacture, and have Manufactured, import import, and conduct regulatory activities regarding the Zydus 200 mg Product in, into into, or for the Territory prior to the Zydus 200 mg Product License Date (but not to Market or Ship the Zydus 200 mg Product prior to the Zydus 200 mg Product License Date) in sufficient quantities to permit Zydus to Market and Ship the Zydus 200 mg Product in, into into, or for the Territory on and after the Zydus 200 mg Product License Date; provided that all Zydus 200 mg Product remain at Zydus’ or its distributor’s warehouse until a Zydus 200 mg Product License Date; and further provided, that Zydus shall re-export (or, at Zydus’ option, destroy) any Zydus 200 mg Product which remains in the Territory at such time that Zydus in good faith determines that no such Final Court Decision will be issued with respect to a Third Party’s Generic Equivalent 200 mg Product and no Accelerated Zydus 200 mg Product License Date will result from such Potential Final Court Decision. To the extent Supernus owns or controls any regulatory exclusivities granted by the FDA that may prevent or hinder Regulatory Approval or Marketing of the Zydus 200 mg Product, Supernus hereby waives, effective as of the date that Zydus is licensed to conduct the applicable activity hereunder, such exclusivities. Supernus shall, if requested by Zydus, send the FDA a written confirmation of Supernus’ grant of the foregoing license under the Licensed Patents and Supernus’ agreement to waive, effective as of the date that Zydus is licensed to conduct the applicable activity hereunder, such regulatory exclusivities with respect to the Zydus 200 mg Product or the Zydus ANDAANDA No. 216167. 2.2 2.2. The license and authorization granted in Section 2.1 and Section 3.1 of this Zydus 200 mg Product License Agreement are referred to herein as the “License and Authorization.” Except to the extent permitted pursuant to Section 11.3, and without derogating from Zydus’s “have Manufactured” rights set forth in Section 2.1, Zydus and its Affiliates shall not have the right to sublicense, assign assign, or transfer any of its rights under the License and Authorization. 2.3 2.3. In the event the [** *] becomes effective due to an [** *] and there are thereafter no longer any [** *] the [** *] in the [** *] (other than [** *] or [** *] subject to substantially the same provisions as set forth in this Section), ** from [**] from [**], [** to ** under the ** ] shall immediately terminate, and [** *] and its [** *] shall [** *] (no [** *] than the [** *] of the [** *] following Zydus’ receipt of such notice) the [** *] and [** *] of [** *] until such subsequent [** *] as another event constituting a [** *] shall have occurred. 2.4 2.4. Except as set forth in the License and Authorization or expressly set forth in this Zydus 200 mg Product License Agreement or other Zydus 200 mg Product Settlement Documents, there are no authorizations, licenses licenses, or rights granted by either Party under this Zydus 200 mg Product License Agreement, by implication, estoppel estoppel, or otherwise, including any right granted to Zydus or its Affiliates to Market or Manufacture any Generic Equivalent 200 mg Product except under the Zydus ANDAANDA No. 216167. All rights not expressly granted by Supernus herein are hereby retained by Supernus▇▇▇▇▇▇▇▇. In addition, except as expressly set forth in this Zydus 200 mg Product License Agreement or other Zydus 200 mg Product Settlement Documents, Supernus explicitly retains the right itself or through an Affiliate to Market an AG Product, and Supernus is free to grant a license under the Licensed Patents or supply AG Product to any Third Party. 2.5 shall ** to ** (i.e., ** shall be **) as ** to the **. ** This portion has been redacted pursuant to a confidential treatment request.

Appears in 1 contract

Sources: Settlement Agreement (Supernus Pharmaceuticals, Inc.)